Glycaemic control, body weight, and safety of tirzepatide versus dulaglutide by baseline glycated haemoglobin level in Japanese patients with type 2 diabetes: A subgroup analysis of the SURPASS J‐mono study
Authors' conclusion
Regardless of baseline HbA1c (≤8.5% or >8.5%), tirzepatide at doses of 5, 10 and 15 mg is effective in Japanese patients with T2D compared with dulaglutide 0.75 mg in terms of glycaemic control and body weight reduction, with an adequate safety profile consistent with previous reports.
Study context
- Population
- Japanese patients with T2D, baseline HbA1c range ≥7.0% to ≤10.0%; subgroups baseline HbA1c ≤8.5% (≤69 mmol/mol) and >8.5% (>69 mmol/mol)randomized · >8.5% (>69 mmol/mol) 203
- Participants
- 636 patients
- Comparison
- Tirzepatide vs dulaglutide 0.75 mg, by baseline HbA1c ≤8.5% vs >8.5%
- Primary endpoint
- Mean change in HbA1c and body weight, and incidence of AEs, by baseline HbA1c subgroup
- Follow-up
- 52 weeks
Methodological detailsexploratory subgroup analysis, 52-week, multicentre, double-blind, parallel, active-controlled, phase 3, Conducted in Japan
- Exploratory subgroup analysis
- 52-week
- Multicentre
- Double-blind
- Parallel
- Active-controlled
- Phase 3
- Conducted in Japan
Primary result
As reported in the abstract
HbA1c change by baseline HbA1c subgroup
- HbA1c change (LSM), baseline HbA1c >8.5%, tirzepatide
- −3.13% to −3.86%
- HbA1c change (LSM), baseline HbA1c >8.5%, dulaglutide
- −1.81%
- HbA1c change (LSM), baseline HbA1c ≤8.5%, tirzepatide
- −2.00% to −2.32%
- HbA1c change (LSM), baseline HbA1c ≤8.5%, dulaglutide
- −1.05%
- Treatment-by-baseline HbA1c subgroup interaction
- P ≤ 0.001
- Body weight LSM change, tirzepatide arms, baseline HbA1c ≤8.5%
- −6.7 to −10.7 kg
- Body weight LSM change, tirzepatide arms, baseline HbA1c >8.5%
- −4.0 to −10.6 kg
- Body weight LSM change, dulaglutide, baseline HbA1c ≤8.5%
- −0.6 kg
- Body weight LSM change, dulaglutide, baseline HbA1c >8.5%
- −0.4 kg
Safety
- Incidence of hypoglycaemia was low; no substantial difference in hypoglycaemia or treatment-emergent adverse events (AEs) between subgroups
Original publication
Glycaemic control, body weight, and safety of tirzepatide versus dulaglutide by baseline glycated haemoglobin level in Japanese patients with type 2 diabetes: A subgroup analysis of the SURPASS J‐mono study. Diabetes Obes Metab. Published 4 October 2023. doi:10.
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